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求助BP2008中维生素C和维C钠、维C钙的内容
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British Pharmacopoeia Volume I & II Monographs: Medicinal and Pharmaceutical Substances Ascorbic Acid General Notices (Ph Eur monograph 0253) C6H8O6 176.1 50-81-7 Action and use Vitamin C. Preparations Ascorbic Acid Injection Ascorbic Acid Tablets Paediatric Vitamins A, C and D Oral Drops Vitamins B and C Injection When Vitamin C is prescribed or demanded, Ascorbic Acid shall be dispensed or supplied. Ph Eur DEFINITION Ascorbic acid contains not less than 99.0 per cent and not more than the equivalent of 100.5 per cent of (5R)-5-[(1S)-1,2-dihydroxyethyl]-3,4-dihydroxyfuran-2(5H)-one. CHARACTERS A white or almost white, crystalline powder or colourless crystals, becoming discoloured on exposure to air and moisture, freely soluble in water, soluble in ethanol (96 per cent). It melts at about 190 °C, with decomposition. IDENTIFICATION First identification B, C. Second identification A, C, D. A. Dissolve 0.10 g in water R and dilute immediately to 100.0 ml with the same solvent. To 10 ml of 0.1 M hydrochloric acid add 1.0 ml of the solution and dilute to 100.0 ml with water R. Measure the absorbance (2.2.25) at the maximum at 243 nm immediately after dissolution. The specific absorbance at the maximum is 545 to 585. B. Examine by infrared absorption spectrophotometry (2.2.24), comparing with the spectrum obtained with ascorbic acid CRS. Examine the substance prepared as discs containing 1 mg. C. The pH (2.2.3) of solution S (see Tests) is 2.1 to 2.6. D. To 1 ml of solution S add 0.2 ml of dilute nitric acid R and 0.2 ml of silver nitrate solution R2. A grey precipitate is formed. TESTS Solution S Dissolve 1.0 g in carbon dioxide-free water R and dilute to 20 ml with the same solvent. Appearance of solution Solution S is clear (2.2.1) and not more intensely coloured than reference solution BY7 (2.2.2, Method II). Specific optical rotation (2.2.7) Dissolve 2.50 g in water R and dilute to 25.0 ml with the same solvent. The specific optical rotation is + 20.5 to + 21.5. Oxalic acid Dissolve 0.25 g in 5 ml of water R. Neutralise to red litmus paper R using dilute sodium hydroxide solution R and add 1 ml of dilute acetic acid R and 0.5 ml of calcium chloride solution R (test solution). Prepare a reference solution as follows: dissolve 70 mg of oxalic acid R in water R and dilute to 500 ml with the same solvent; to 5 ml of this solution add 1 ml of dilute acetic acid R and 0.5 ml of calcium chloride solution R (reference solution). Allow the solutions to stand for 1 h. Any opalescence in the test solution is not more intense than that in the reference solution (0.2 per cent). Related substances The thresholds indicated under Related substances (Table 2034.-1) in the general monograph Substances for pharmaceutical use (2034) do not apply. Copper Not more than 5.0 ppm of Cu, determined by atomic absorption spectrometry (2.2.23, Method I). Test solution Dissolve 2.0 g of the substance to be examined in 0.1 M nitric acid and dilute to 25.0 ml with the same acid. Reference solutions Prepare reference solutions containing 0.2 ppm, 0.4 ppm and 0.6 ppm of Cu by diluting copper standard solution (10 ppm Cu) R with 0.1 M nitric acid. Measure the absorbance at 324.8 nm using a copper hollow-cathode lamp as a source of radiation and an air-acetylene flame. Adjust the zero of the apparatus using 0.1 M nitric acid. Iron Not more than 2.0 ppm of Fe, determined by atomic absorption spectrometry (2.2.23, Method I). Test solution Dissolve 5.0 g of the substance to be examined in 0.1 M nitric acid and dilute to 25.0 ml with the same acid. Reference solutions Prepare reference solutions containing 0.2 ppm, 0.4 ppm and 0.6 ppm of Fe by diluting iron standard solution (20 ppm Fe) R with 0.1 M nitric acid. Measure the absorbance at 248.3 nm using an iron hollow-cathode lamp as a source of radiation and an air-acetylene flame. Adjust the zero of the apparatus using 0.1 M nitric acid. Heavy metals (2.4.8) Dissolve 2.0 g in water R and dilute to 20 ml with the same solvent. 12 ml of the solution complies with test A (10 ppm). Prepare the reference solution using lead standard solution (1 ppm Pb) R. Sulphated ash (2.4.14) Not more than 0.1 per cent, determined on 1.0 g. ASSAY Dissolve 0.150 g in a mixture of 10 ml of dilute sulphuric acid R and 80 ml of carbon dioxide-free water R. Add 1 ml of starch solution R. Titrate with 0.05 M iodine until a persistent violet-blue colour is obtained. 1 ml of 0.05 M iodine is equivalent to 8.81 mg of C6H8O6. STORAGE Store in a non-metallic container, protected from light. Ph Eur |
4楼2008-12-18 19:36:17
3楼2008-12-18 18:12:18
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British Pharmacopoeia Volume I & II Monographs: Medicinal and Pharmaceutical Substances Calcium Ascorbate General Notices (Ph Eur monograph 1182) C12H14CaO12,2H2O 426.3 5743-28-2 Action and use Pharmaceutical aid. Ph Eur DEFINITION Calcium di[(R)-2-[(S)-1,2-dihydroxyethyl]-4-hydroxy-5-oxo-2H-furan-3-olate] dihydrate. Content 99.0 per cent to 100.5 per cent of C12H14CaO12,2H2O. CHARACTERS Appearance White or slightly yellowish, crystalline powder. Solubility Freely soluble in water, practically insoluble in ethanol (96 per cent). IDENTIFICATION First identification A, B, E. Second identification A, C, D, E. A. Specific optical rotation (see Tests). B. Infrared absorption spectrophotometry (2.2.24). Comparison Ph. Eur. reference spectrum of calcium ascorbate. C. Dilute 1 ml of solution S (see Tests) to 10 ml with water R. To 2 ml of the solution add 0.2 ml of a 100 g/l solution of ferrous sulphate R. A deep violet colour develops. D. To 1 ml of solution S add 0.2 ml of dilute nitric acid R and 0.2 ml of silver nitrate solution R2. A grey precipitate is formed. E. The substance gives reaction (b) of calcium (2.3.1). TESTS Solution S Dissolve 5.00 g in carbon dioxide-free water R and dilute to 50.0 ml with the same solvent. Appearance of solution Solution S is clear (2.2.1) and not more intensely coloured than reference solution Y6 (2.2.2, Method II). Examine the colour of the solution immediately after preparation of the solution. pH (2.2.3) 6.8 to 7.4 for solution S. Specific optical rotation (2.2.7) + 95 to + 97 (dried substance), determined using freshly prepared solution S. Related substances The thresholds indicated under Related substances (Table 2034.-1) in the general monograph Substances for pharmaceutical use (2034) do not apply. Fluorides Maximum 10.0 ppm. Potentiometry (2.2.36, Method I). Test solution In a 50 ml volumetric flask, dissolve 1.000 g in a 10.3 g/l solution of hydrochloric acid R, add 5.0 ml of fluoride standard solution (1 ppm F) R and dilute to 50.0 ml with a 10.3 g/l solution of hydrochloric acid R. To 20.0 ml of the solution add 20.0 ml of total-ionic-strength-adjustment buffer R and 3 ml of an 82 g/l solution of anhydrous sodium acetate R. Adjust to pH 5.2 with ammonia R and dilute to 50.0 ml with distilled water R. Reference solutions To 0.25 ml, 0.5 ml, 1.0 ml, 2.0 ml and 5.0 ml of fluoride standard solution (10 ppm F) R add 20.0 ml of total-ionic-strength-adjustment buffer R and dilute to 50.0 ml with distilled water R. Indicator electrode Fluoride selective. Reference electrode Silver-silver chloride. Take into account the addition of fluoride to the test solution for the calculation. Copper Maximum 5.0 ppm. Atomic absorption spectrometry (2.2.23, Method I). Test solution Dissolve 2.0 g in a 9.7 g/l solution of nitric acid R and dilute to 25.0 ml with the same acid solution. Reference solutions Prepare the reference solutions using copper standard solution (10 ppm Cu) R, diluting with a 9.7 g/l solution of nitric acid R. Source Copper hollow-cathode lamp. Wavelength 324.8 nm. Atomisation device Air-acetylene flame. Iron Maximum 2.0 ppm. Atomic absorption spectrometry (2.2.23, Method I). Test solution Dissolve 5.0 g in a 9.7 g/l solution of nitric acid R and dilute to 25.0 ml with the same acid solution. Reference solutions Prepare the reference solutions using iron standard solution (10 ppm Fe) R, diluting with a 9.7 g/l solution of nitric acid R. Source Iron hollow-cathode lamp. Wavelength 248.3 nm. Atomisation device Air-acetylene flame. Heavy metals (2.4.8) Maximum 10 ppm. 2.0 g complies with test D. Prepare the reference solution using 2.0 ml of lead standard solution (10 ppm Pb) R. Loss on drying (2.2.32) Maximum 0.1 per cent, determined on 1.000 g by drying in an oven at 100-105 °C for 2 h. ASSAY Dissolve 80.0 mg in a mixture of 10 ml of dilute sulphuric acid R and 80 ml of carbon dioxide-free water R. Add 1 ml of starch solution R. Titrate with 0.05 M iodine until a persistent violet-blue colour is obtained. 1 ml of 0.05 M iodine is equivalent to 10.66 mg of C12H14CaO12,2H2O. STORAGE In a non-metallic container, protected from light. Ph Eur |
5楼2008-12-18 19:40:32
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British Pharmacopoeia Volume I & II Monographs: Medicinal and Pharmaceutical Substances Sodium Ascorbate General Notices (Ph Eur monograph 1791) C6H7NaO6 198.1 134-03-2 Action and use Pharmaceutical aid. Ph Eur DEFINITION Sodium (2R)-2-[(1S)-1,2-dihydroxyethyl]-4-hydroxy-5-oxo-2,5-dihydrofuran-3-olate. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance White or yellowish, crystalline powder or crystals. Solubility Freely soluble in water, sparingly soluble in ethanol (96 per cent), practically insoluble in methylene chloride. IDENTIFICATION First identification B, D. Second identification A, C, D. A. Specific optical rotation (2.2.7) (see Tests). B. Infrared absorption spectrophotometry (2.2.24). Preparation Discs. Comparison sodium ascorbate CRS. C. To 1 ml of solution S (see Tests) add 0.2 ml of dilute nitric acid R and 0.2 ml of silver nitrate solution R2. A grey precipitate is formed. D. 1 ml of solution S gives reaction (a) of sodium (2.3.1). TESTS Solution S Dissolve 10.0 g in carbon dioxide-free water R prepared from distilled water R and dilute to 100.0 ml with the same solvent. Appearance of solution Solution S is clear (2.2.1) and not more intensely coloured than reference solution Y6 or BY6 (2.2.2, Method II). Examine the colour immediately after preparation of the solution. pH (2.2.3) 7.0 to 8.0 for solution S. Specific optical rotation (2.2.7) + 103 to + 108 (dried substance), determined on freshly prepared solution S. Oxalic acid Maximum 0.3 per cent. Test solution Dissolve 0.25 g in 5 ml of water R. Add 1 ml of dilute acetic acid R and 0.5 ml of calcium chloride solution R. Reference solution Dissolve 70 mg of oxalic acid R in water R and dilute to 500 ml with the same solvent; to 5 ml of the solution add 1 ml of dilute acetic acid R and 0.5 ml of calcium chloride solution R. Allow the solutions to stand for 1 h. Any opalescence in the test solution is not more intense than that in the reference solution. Related substances The thresholds indicated under Related substances (Table 2034.-1) in the general monograph Substances for pharmaceutical use (2034) do not apply. Benzene (2.4.24, System A) Maximum 2 ppm. Sulphates (2.4.13) Maximum 150 ppm. To 10 ml of solution S add 2 ml of hydrochloric acid R1 and dilute to 15 ml with distilled water R. Copper Maximum 5.0 ppm. Atomic absorption spectrometry (2.2.23, Method I). Test solution Dissolve 2.0 g in 0.1 M nitric acid and dilute to 25.0 ml with the same solvent. Reference solutions Prepare reference solutions (0.2 ppm, 0.4 ppm and 0.6 ppm) by diluting copper standard solution (10 ppm Cu) R with 0.1 M nitric acid. Source Copper hollow-cathode lamp. Wavelength 324.8 nm. Atomisation device Air-acetylene flame. Iron Maximum 2.0 ppm. Atomic absorption spectrometry (2.2.23, Method I). Test solution Dissolve 5.0 g in 0.1 M nitric acid and dilute to 25.0 ml with the same solvent. Reference solutions Prepare reference solutions (0.2 ppm, 0.4 ppm and 0.6 ppm) by diluting iron standard solution (20 ppm Fe) R with 0.1 M nitric acid. Source Iron hollow-cathode lamp. Wavelength 248.3 nm. Atomisation device Air-acetylene flame. Nickel Maximum 1.0 ppm. Atomic absorption spectrometry (2.2.23, Method I). Test solution Dissolve 10.0 g in 0.1 M nitric acid and dilute to 25.0 ml with the same solvent. Reference solutions Prepare reference solutions (0.2 ppm, 0.4 ppm and 0.6 ppm) by diluting nickel standard solution (10 ppm Ni) R with 0.1 M nitric acid. Source Nickel hollow-cathode lamp. Wavelength 232.0 nm. Atomisation device Air-acetylene flame. Heavy metals (2.4.8) Maximum 10 ppm. Dissolve 2.0 g in water R and dilute to 20 ml with the same solvent. 12 ml of the solution complies with test A. Prepare the reference solution using lead standard solution (1 ppm Pb) R. Loss on drying (2.2.32) Maximum 0.25 per cent, determined on 1.000 g by drying in an oven at 100-105 °C. ASSAY Dissolve 80 mg in a mixture of 10 ml of dilute sulphuric acid R and 80 ml of carbon dioxide-free water R. Add 1 ml of starch solution R. Titrate with 0.05 M iodine until a persistent violet-blue colour is obtained. 1 ml of 0.05 M iodine is equivalent to 9.91 mg of C6H7NaO6. STORAGE In a non-metallic container, protected from light. Ph Eur |
6楼2008-12-18 19:44:46
